Kinapse

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

Senior Medical Writer - CSR Writing

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Updated: June 15, 2021
Location: Gurgaon, HR, India
Job ID: 132029


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Overview

 Do you want to work in an environment and culture where you can thrive, develop and advance?

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

An opportunity has arisen for a Senior Medical Writer at the Consultant Level in Bangalore/Gurgaon.

 

 

Responsibilities

  • Independently authors or leads authoring, including editing of documents such as:
  • Clinical study documents or documents for regulatory submission e.g., protocols, clinical study reports, patient narratives, investigator brochures
  • External scientific communications e.g., manuscripts, abstracts, standard response documents, FAQs, response to authorities
  • May independently author or lead authoring of complex documents such as INDs, clinical summaries and overviews, briefing documents, response to authorities, and PIPs
  • Provides quality assurance and training, and may provide technical mentoring, of team members depending upon project requirement
  • Supports work allocation and provides oversight to team members in execution of their project responsibilities
  • As a Subject Matter Expert (SME), may provide internal advice on Development Operations services based on expertise to support business development and training
  • Participates in recruitment when required
  • Displays and supports Kinapse values and expected behaviours related to team working and projects
  • Systematically review or perform quality control checks of documents prepared by junior colleagues against pre‑specified check‑lists and follow‑up independently until final submission, or as assigned
  • Support and implement the development of project‑specific and general quality processes to ensure compliance with client and Kinapse quality standards
  • Ensure personal, and support project team, compliance with client and Kinapse procedures and SOPs

Job Requirements

  • Active, continuous demonstration of the Kinapse values
  • Degree, or advanced level degree in a life science discipline
  • Experience and technical skills within Medical Writing or Medical Information, as a part of a pharmaceutical company or CRO
  • Strong analytical capabilities, familiarity and comfort with scientific and clinical data
  • Commitment to ensuring the highest quality outputs are provided, including high attention to detail
  • Significant knowledge of regulatory requirements or guidance pertaining to medical writing or medical Information
  • Demonstrate the ability to impart knowledge of industry or functional terminology to other team members
  • Effective team member, and matrix leader for small teams
  • Integrity, credibility, and commitment to building the Kinapse brand in the marketplace
  • Excellent client relationship management skills, professional service mentality

 

If you want to be part of a progressive, forward-thinking company and want to make a difference then we want to hear from you.

We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion

 

 

 


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